1
ASBM European Prescribers Survey
Kevin Olson, CEOIndustry Standard Research
[email protected] x701
November, 2013
Industry Standard Research
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Methodology
• 470 Prescribers were recruited from 5 countries in Western Europe– UK– France– Germany– Italy– Spain
• 15 minute web-based survey
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SAMPLE CHARACTERISTICS
Demographic Data
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Geographic Representation
UK; 20%
France; 20%
Germany; 20%
Italy; 20%
Spain; 20%
N=470
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Oncology
Endocrinology
Neurology
Dermatology
Rheumatology
Nephrology
0% 2% 4% 6% 8% 10% 12% 14% 16% 18% 20%
16%
16%
16%
17%
17%
18%
Primary therapeutic area
“Please indicate your primary practice area or therapeutic area in which you practice?” (N=470)
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Other
Multi-specialty clinic
Community setting
Private, family practice
Academic medical center
Hospital
0% 10% 20% 30% 40% 50% 60% 70%
1%
2%
8%
8%
24%
58%
Practice setting
“Which of the following best describes the type of practice in which you work?” (N=470)
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More than 30 years
21-30 years
11-20 years
6-10 years
1-5 years
0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50%
7%
28%
46%
18%
1%
Length of time in healthcare sector
“How long have you been working in the healthcare sector?” (N=470)
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More than 50
20-50
Fewer than 20
0% 10% 20% 30% 40% 50% 60% 70% 80%
70%
29%
1%
Average number of appointments
“On average, about how many patient appointments do you conduct per week?” (N=470)
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92%
8%
Yes No
Prescribing biologics
“Do you prescribe biologic medicines in your practice?” (N=470)
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76%
12%
12%
Yes No Don't Know
Treatment of patients prescribed biologics by others
“Do you commonly treat patients who you are aware are being prescribed biologic medicines by another health care provider?” (N=470)
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EPAR (European Public Assessment Report)
Colleagues
Medical info from manufacturer
National or hospital formulary
SmPC/Label
Published literature
0% 20% 40% 60% 80% 100%
19%
21%
34%
37%
43%
49%
43%
66%
57%
50%
43%
48%
38%
14%
9%
13%
14%
3%
Always Occasionally Never
Use of information sources
“How often do you use each of the following sources to learn about the details of a medicine for prescribing and monitoring?” (N=470)
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EXECUTIVE SUMMARY
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Executive Summary
Biosimilars Knowledge• A need for Biosimilar
education still exists - 24% of prescribers do not consider themselves familiar with these medicines.
• 37% of prescribers are unaware that clinical trials for a single indication leads to approval for multiple indications.
22%
54%
20%
4%
Familiarity with Biosimilars
Very Familiar - Complete under-standingFamiliar - Basic un-derstandingHeard of them - Can't defineNever heard of them
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Executive Summary
Identifying the Drug in Patient Records• Whether by brand, non
proprietary / generic or both varies considerably.– 32% use both– 30% use brand only– 24% us non proprietary
name only– 14% - varies by medicine
• When reporting AEs, 54% use both brand and non proprietary names
32%
30%
24%
14%
Identifying Drugs
Brand and GenericBrand OnlyGeneric OnlyVaries by Medicine
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Executive Summary
Naming Implications“If two medicines have the same non-proprietary scientific name, does this suggest to you or imply…• Structurally identical – Yes = 53%• Safely receive either with the same results – Yes
= 47%• Safely switch during treatment, with the same
results – Yes = 39%• Approved for the same indications – Yes = 61%
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Executive Summary
Pharmacy Substitution• 72% of prescribers
consider it “Critical” or “Very Important” to decide which biologic is most suitable.
• 74% regard DAW authority as “Critical” or “Very Important”
24%
48%
23%
4%
1%
Importance of Sole Authority
CriticalVery ImportantSomewhat ImportantSlightly ImportantNot Important
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Executive Summary
Notification• 77% consider it
“Critical” or “Very Important” to receive notification of a switch
• 3% consider pharmacy level substitution completely acceptable
• 35% consider switching to a biosimilar acceptable, pending agreement of the prescriber
62%
35%
3%
Pharmacist Decision Making
Not acceptableAcceptable with prior agreement with clinicianTotally acceptable
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FAMILIARITYStudy Data
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Understanding Statistical Significance
• ISR has provided regional statistical significance tests for each question
• When highlighting the existence of segment differences, ISR uses the following format: Each column (country) has been assigned a letter (A thru E) and when a statistically significant difference occurs between segments, it is noted by one of these letters
• Below are the regional statistical significance results of the question asking whether or not physicians prescribe biologics– How to read table: Physicians in Italy (C: 14%) are more likely to not
prescribe biologics than physicians in France (A: 4%) and Germany (B: 3%)
TotalN=470
FranceN=93
A
GermanyN=94
B
ItalyN=96
C
SpainN=92
D
UKN=95
E
No 8% 4% 3% 14% A,B 14% A,B,E 5%
Yes 92% 96% C,D 97% C,D 86% 86% 95% D
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Have never heard of them
I've heard of them but could not define them
Familiar, have a basic understanding of them
Very familiar, I have a complete understanding of them
0% 5% 10%
15%
20%
25%
30%
35%
40%
45%
50%
1%
11%
46%
43%
Familiarity with biologic medicines
“How familiar are you with biologic medicines?” (N=470)
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Significance: Familiarity with biologic medicines
TotalN=470
FranceN=93
A
GermanyN=94
B
ItalyN=96
C
SpainN=92
D
UKN=95
E
Very Familiar 43% 30% 39% 42% 62% A,B,C,E 40%
Familiar 46% 44% 48% D 50% D 32% 54% D
I’ve heard of them 11% 20% C,D,E 13% 8% 7% 6%
Have never heard of them 1% 5% B,C,E 0% 0% 0% 0%
• A higher proportion of physicians from Spain (62%) are “very familiar” with biologic medicines than all other geographies.
• French prescribers indicate a lower level of awareness than most.
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Have never heard of them
I've heard of them but could not define them
Familiar, have a basic understanding of them
Very familiar, I have a complete understanding of them
0% 10% 20% 30% 40% 50% 60%
4%
20%
54%
22%
Familiarity with biosimilar medicines
“How familiar are you with biosimilar medicines?” (N=470)
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Significance: Familiarity with biosimilar medicines
TotalN=470
FranceN=93
A
GermanyN=94
B
ItalyN=96
C
SpainN=92
D
UKN=95
E
Very Familiar 22% 17% 21% 26% 28% 19%
Familiar 54% 44% 59% A 57% 49% 59% A
I’ve heard of them 20% 30% B,C,E 16% 15% 21% 18%
Have never heard of them 4% 9% 4% 2% 2% 4%
• A higher proportion of physicians from Germany and UK are “familiar” with biologic medicines than physicians from France.
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Other
Clinical trial participation
Innovator company sponsored education
Biosimilar company sponsored education
Self-study
Seminar and conference attendance
0% 5% 10%15%20%25%30%35%40%45%50%
2%
2%
2%
11%
35%
47%
How you became familiar
“How did you become familiar with biosimilar medicines?” (N=357)
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Significance: How you became familiar
TotalN=357
FranceN=57
A
GermanyN=75
B
ItalyN=80
C
SpainN=71
D
UKN=74
E
Biosimilar company sponsored education 11% 7% 7% 13% 21% A,B,E 7%
Clinical trial participation 2% 5% 0% 3% 4% 0%
Innovator company sponsored education 2% 0% 1% 4% 4% 0%
Self-study 35% 37% D 44% D 31% 20% 45% DSeminar and conference
attendance 47% 47% 47% 50% 48% 45%
Other 2% 4% 1% 0% 3% 4%
• Prescribers in Spain are more likely to have become familiar with biosimilars through a company sponsored education program than most.
• Prescribers in Spain are less likely to have become familiar with biosimilars through self study.
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Via online websites
Through medical societies
Through pharmaceutical companies
During international medical conferences / symposia
Through scientific publications
During national medical conferences / symposia
0% 5% 10% 15% 20% 25% 30% 35% 40%
6%
8%
10%
14%
28%
34%
How you would prefer to learn about biosimilars
“How would you prefer to learn about biosimilars?” (N=113)
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Significance: How you would prefer to learn…
TotalN=113
FranceN=36
A
GermanyN=19
B
ItalyN=16
C
SpainN=21
D
UKN=21
E
During international medical conferences / symposia 14% 17% 11% 13% 5% 24%
During national medical conferences / symposia 34% 44% C 26% 13% 38% 33%
Through medical societies 8% 14% 5% 6% 0% 10%
Through pharmaceutical companies 10% 3% 5% 19% 19% 10%
Through scientific publications 28% 19% 37% 44% 38% 14%
Via online websites 6% 3% 16% 6% 0% 10%
• A higher proportion of physicians from France (44%) would prefer to learn about bioslimilars through national medical conferences/symposia than physicians from Italy (13%).
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63%
37%
Biosimilar approval awareness
“Are you aware that a biosimilar may be approved for several or all indications of the innovator product on the basis of clinical trials in only one of those indications?” (N=470)
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Significance: Biosimilar approval awareness
TotalN=470
FranceN=93
A
GermanyN=94
B
ItalyN=96
C
SpainN=92
D
UKN=95
E
No 37% 37% C 48% C 22% 35% C 45% C
Yes 63% 63% 52% 78% A,B,D,E 65% 55%
• Italian prescribers report a higher level of awareness than those in other countries measured.
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PRESCRIBING, RECORDING, & AE REPORTING
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95%
5%
Yes No
Medication identification – Patient record
“When you prescribe medicine, including biologics, do you identify the medicine in the patient record?” (N=470)
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TotalN=470
FranceN=93
A
GermanyN=94
B
ItalyN=96
C
SpainN=92
D
UKN=95
E
No 5% 0% 13% A,C,E 4% 8% A,E 0%
Yes 95% 100% B,D 87% 96% B 92% 100% B,D
• The practice is quite common across the board, however, it is less likely in Germany and Spain.
Significance: Medication identification – patient record
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89%
11%
Yes No
Medication identification – Other providers
“When you treat a patient receiving a biologic medicine prescribed by another health care provider, do you identify the medicine in the patient record?” (N=470)
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TotalN=470
FranceN=93
A
GermanyN=94
B
ItalyN=96
C
SpainN=92
D
UKN=95
E
No 11% 3% 33% A,C,D,E 3% 5% 12% A,C
Yes 89% 97% B,E 67% 97% B,E 95% B 88% B
• A higher proportion of physicians from the UK and Germany do not record this information than from other countries.
Significance: Medication identification – Other providers
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It varies by medicine
Non-proprietary / generic name
Brand name
Brand name and non proprietary name
0% 5% 10% 15% 20% 25% 30% 35%
14%
24%
30%
32%
Biologic recording – Patient record
“How do you identify a biologic medicine for prescription or recording in a patient record? Do you identify the medicine by brand name (eg, Remicade, Herceptin) or non-proprietary name (eg, infliximab, trastuzumab)?” (N=417)
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TotalN=417
FranceN=90
A
GermanyN=63
B
ItalyN=93
C
SpainN=87
D
UKN=84
E
Brand name 32% 53% C,D,E 40% D,E 27% 20% 20%
Brand name and non-proprietary name 30% 21% 17% 42% A,B 37% A,B 30%
It varies by medicine 14% 17% C 29% C,D,E 6% 8% 13%
Non-proprietary name / generic name 24% 9% 14% 25% A 36% A,B 37% A,B
• French and German prescribers are more likely to record the products by brand name.
• Italy and Spain are more likely to use both brand and generic.
Significance: Biologic recording – Patient record
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Non-proprietary / generic name
Product name
Both brand name and non-proprietary name
0% 10% 20% 30% 40% 50% 60%
17%
29%
54%
Biologic recording – Adverse events
“Physicians play an important role in the identification and reporting of unexpected or serious adverse events to their national regulatory agencies and manufacturers. In the context of identifying a biologic (or, if you don’t prescribe biologics, any other drug) for purposes of reporting an adverse event, how do you identify the medicine?” (N=470)
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TotalN=470
FranceN=93
A
GermanyN=94
B
ItalyN=96
C
SpainN=92
D
UKN=95
E
Product name 29% 58% B,C,D,E 36% C,D,E 19% 14% 19%
Both brand name and non-proprietary
name54% 32% 51% A 59% A 70% A 56% A
Non-proprietary / generic name 17% 10% 13% 22% A 16% 25% A,B
• French and German prescribers are more likely to record the products by brand name.
Significance: Biologic recording – Adverse events
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40%
33%
27%
Always Sometimes Never
“How often do you include the batch number when reporting adverse events?” (N=470)
Batch number inclusion
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TotalN=470
FranceN=93
A
GermanyN=94
B
ItalyN=96
C
SpainN=92
D
UKN=95
E
Always 40% 30% 45% A 57% A,D,E 34% 35%
Sometimes 33% 32% 35% 31% 23% 43% D
Never 27% 38% B,C,E 20% 11% 43% B,C,E 22% C
• Italy and Germany are more likely to “always” include batch number.
• France and Spain are more likely to “never” include it.
Significance: Batch number inclusion
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Reason for not including batch number
“If your answer to question 18 was ‘Sometimes’ or ‘Never’, what are the main reasons for not reporting the batch number?” (N=281)
Other
Form / System does not have dedicated field
Not sure where to find this information
Forget to include this information
Do not have it available at the time of reporting
0% 5% 10%15%20%25%30%35%40%45%50%
4%
8%
19%
23%
46%
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TotalN=281
FranceN=65
A
GermanyN=52
B
ItalyN=41
C
SpainN=61
D
UKN=62
E
Do not have it available at the
time of reporting46% 37% 62% A,D 41% 43% 48%
Forget to include this information 23% 28% 25% 17% 23% 19%
Form / System does not have dedicated field
8% 5% 4% 22% A,B,E 10% 5%
Not sure where to find this information
19% 29% B,C 8% 12% 16% 24% B
Other 4% 2% 2% 7% 8% 3%
• A higher proportion of physicians from Germany (62%) say the reason they do not include the batch number is they “do not have it available at the time of reporting.”
Significance: Reason for not including batch number
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53%
32%
15%
Yes No No Opinion
Non-proprietary name implications – Structurally Identical?
“If two medicines have the same non-proprietary scientific name, does this suggest to you or imply that the medicines are structurally identical?” (N=470)
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TotalN=470
FranceN=93
A
GermanyN=94
B
ItalyN=96
C
SpainN=92
D
UKN=95
E
No32% 28% 24% 43% A,B,E 40% B,E 24%
Yes 53% 59% C,D 68% C,D 44% 37% 59% C,D
No opinion15% 13% 7% 14% 23% B 17% B
• Prescribers in France, Germany and UK are more likely to believe these products are structurally identical.
Significance: Non-proprietary name implications – Structurally Identical?
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47%
40%
13%
Yes No No Opinion
“If two medicines have the same non-proprietary scientific name, does this suggest to you or imply that a patient could safely receive either product and expect the same result?” (N=470)
Non-proprietary name implications - Safety
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TotalN=470
FranceN=93
A
GermanyN=94
B
ItalyN=96
C
SpainN=92
D
UKN=95
E
No 40% 29% 43% 48% A 46% A 35%
Yes 47% 57% C,D 50% 40% 38% 49%
No opinion 13% 14% 7% 13% 16% 16%
• Prescribers in France are more likely to believe these products can be safely switched than those in Italy and Spain.
Significance: Non-proprietary name implications - Safety
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39%
45%
16%
Yes No No Opinion
Non-proprietary name implications – Substitution
“If two medicines have the same non-proprietary scientific name, does this suggest to you or imply that a patient could be safely switched between the products during a course of treatment and expect the same result as treatment with only one of the products?” (N=470)
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TotalN=470
FranceN=93
A
GermanyN=94
B
ItalyN=96
C
SpainN=92
D
UKN=95
E
No 45% 34% 50% A 52% A 40% 48%
Yes 39% 49% D 37% 39% 34% 38%
No opinion 16% 16% 13% 9% 26% B,C,E 14%
• French prescribers are more likely to believe this than prescribers in Spain.
Significance: Non-proprietary name implications – Substitution
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61%
31%
9%
Yes No No Opinion
Non-proprietary name implications – Approval
“If two medicines have the same non-proprietary scientific name, does this suggest to you or imply that the medicines are approved for the same indications?” (N=470)
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TotalN=470
FranceN=93
A
GermanyN=94
B
ItalyN=96
C
SpainN=92
D
UKN=95
E
No 31% 28% 35% 36% 27% 26%
Yes 61% 68% 59% 60% 58% 59%
No opinion 9% 4% 6% 3% 15% A,C 15% A,C
• Opinions are stable across countries.
Significance: Non-proprietary name implications – Approval
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PHARMACY SUBSTITUTION
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Not important
Slightly important
Somewhat important
Very important
Critical
0% 10% 20% 30% 40% 50% 60%
1%
4%
23%
48%
24%
Importance of prescribing authority
“How important is it to you to have the sole authority to decide, together with your patients, the most suitable biologic medicine for their disease?” (N=470)
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TotalN=470
FranceN=93
A
GermanyN=94
B
ItalyN=96
C
SpainN=92
D
UKN=95
E
Critical 24% 25% C 16% 34% B,E 33% B,E 11%
Very important 48% 47% 38% 46% 55% B 55% B
Somewhat important 23% 16% 37% A,C,D 20% 12% 27% D
Slightly important 4% 9% C,D 6% C,D 0% 0% 7% C,D
Not important 1% 3% 2% 0% 0% 0%
• Prescribers in Italy and Spain hold stronger opinions about this than most others.
Significance: Importance of prescribing authority
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Not important
Slightly important
Somewhat important
Very important
Critical
0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50%
1%
5%
20%
47%
27%
Importance of DAW
“In a situation where substitution by a pharmacist was an option in your country, how important would it be to you to have the authority to designate a biologic medicine as ‘DISPENSE AS WRITTEN’ or ‘DO NOT SUBSTITUTE’?” (N=470)
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TotalN=470
FranceN=93
A
GermanyN=94
B
ItalyN=96
C
SpainN=92
D
UKN=95
E
Critical 27% 25% B 13% 40% A,B,E 41% A,B,E 15%
Very important 47% 47% 46% 33% 50% C 59% C
Somewhat important 20% 16% 30% A,D 25% D 9% 18%
Slightly important 5% 10% C,D 7% D 2% 0% 7% D
Not important 1% 2% 4% 0% 0% 1%
• Prescribers in Italy and Spain hold stronger opinions about this than most others.
Significance: Importance of DAW
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Not important
Slightly important
Somewhat important
Very important
Critical
0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50%
1%
6%
16%
47%
30%
Importance of substitution notification
“How important would it be for you to be notified by the pharmacist that your patient has received a biologic other than the one you prescribed, if the patient was receiving chronic (repeated) treatment?” (N=470)
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TotalN=470
FranceN=93
A
GermanyN=94
B
ItalyN=96
C
SpainN=92
D
UKN=95
E
Critical 30% 33% B 20% 32% 45% B,E 22%Very important 47% 45% 45% 42% 47% 56%
Somewhat important16% 15% 23% D,E 23% D,E 7% 11%
Slightly important6% 4% 9% 3% 2% 9%
Not important1% 2% 3% 0% 0% 2%
• Notification is important across countries• Prescribers in Germany and UK feel less strongly than most
Significance: Importance of substitution notification
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Totally acceptable
Acceptable, provided such an exchange has been agreed with clinicians for these biologics in advance
Not acceptable - only the prescriber should make this determination
0% 20% 40% 60% 80%
3%
35%
62%
Acceptability of pharmacist determination
“How acceptable would it be for you if the pharmacist made the determination which biologic (innovator or biosimilar) to dispense to your patient on initiation of treatment?” (N=470)
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TotalN=470
FranceN=93
A
GermanyN=94
B
ItalyN=96
C
SpainN=92
D
UKN=95
E
Totally acceptable 3% 4% 5% 2% 0% 2%
Acceptable, provided such exchange has been agreed with clinicians for
these biologics in advance
35% 43% C 33% 21% 34% C 45% C
Not acceptable 62% 53% 62% 77% A,B,E 66% 53%
• Unilateral decision making at the pharmacy is not acceptable to prescribers. This sentiment is strongest among prescribers in Italy.
Significance: Acceptability of pharmacist determination
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A patient who has not received a specific brand of a biological medicine for a substantial period
A patient who has not received any biologic treatment of this class of medicines for a substantial period of time (> 12 months)
A patient who has never received a specific brand of a biological medicine
A patient who has never received any biologic treatment of this class of medicines
0% 20% 40% 60% 80%
2%
8%
14%
76%
Defining “bio-naive”
“How do you define “bio-naïve” patients with respect to biologics?” (N=470)
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TotalN=470
FranceN=93
A
GermanyN=94
B
ItalyN=96
C
SpainN=92
D
UKN=95
E
A patient who has never received a specific brand of biological medicine 14% 20% C,D 28% C,D,E 6% 5% 11%
A patient who has never received any biological treatment of this class 76% 74% 66% 79% B 80% B 82% BA patient who has not received a
specific brand of a biological medicine for a substantial period of
time2% 2% 0% 1% 4% 1%
A patient who has not received any biologic treatment of this class of
medicines for a substantial period of time
8% 3% 5% 14% A 10% 6%
Other 0% 0% 1% 0% 0% 0%
• Most believe this means “a patient who has never received any biological treatment of this class.” This is less likely in Germany than most.
Significance: Defining “bio-naive”
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